UK PMS Regulations for Medical Devices: Part 2 – Vigilance & Reporting Requirements

What key changes were introduced with the new UK PMS Regulation?

1.    Manufacturer’s Notification requirements

Notification to the UK approved body (UKAB) and UK responsible person (UKRP)

Manufacturers are now required to inform their UK Responsible Person (UKRP), and the UK Approved Body (UKAB) of all preventive and corrective actions taken after device certification for the GB market. The UKAB will assess whether there is an impact of the device certification. Where a manufacturer undertakes FSCA they should ensure both the UKAB and UKRP are aware in advance of initiating the action.

Notification to the MHRA and timeline to report

The manufacturer or UKRP shall notify the MHRA about serious incidents, FSCAs and trend report using the MORE portal. When submitting an incident report, the manufacturer will need to include additionally to what was previous required, the UDI (where available).

What Are the Reporting Timelines?

The reporting deadlines have been largely maintained, with one key change:
•    Serious public health threats – within 2 days
•    Death or unanticipated serious deterioration in health – within 10 days
•    Anticipated serious deterioration in health – now within 15 days (previously 30 days)

Additionally, if requested, manufacturers must provide the MHRA with any new information related to an ongoing incident investigation or FSCA within 3 UK working days.

Additional Requirements for Incident Investigations

If an incident investigation involves device examination or destructive testing, manufacturers must notify the MHRA before altering the device or any affected batch sample. Any changes that could impact a future evaluation of the incident's cause must be communicated in advance.

Furthermore, if the MHRA identifies an incident, risk, or safety concern, the manufacturer is required to conduct an investigation and submit a report to the MHRA.

What incidents must be reported to the MHRA?

All serious incidents must be reported to the MHRA if they meet all three criteria:

1.    An event or issues has occurred - This includes for example malfunctions, deterioration of the device performance or characteristics, shortcoming of device design, usability issues, side effects or where device testing, labelling and IFU or scientific information indicates a potential or actual issue.
2.    The device is suspected to be a contributory cause - This applies even if the issue arises as a side effect.
3.    The incident resulted or could have resulted in death or serious health deterioration – This includes cases where medical intervention (e.g., surgery, self-administered treatment, or implant revision) prevented a serious outcome. Use errors must also be reported if they present a risk of serious deterioration in health.

Reporting process

•    Manufacturers must submit an initial report with the required details. This has been clearly defined.
•    Carry out investigation, review the risk analysis considering any proposed preventive and correct actions
•    A final report must be submitted to MHRA once the investigation is complete.
•    If an investigation is expected to take months, manufacturers should send interim updates via the MORE portal.

Non-Serious Incidents & Trend Reporting

Non-serious incidents do not require individual reporting but must be:
•    Documented in the PMS system
•    Included in trend reports if they meet this type of reporting criteria.

2.    Trend reporting obligations: Identifying Safety Risks Early

Manufacturers must submit trend reports for both serious incidents meeting reporting criteria and non-serious incidents that do not qualify for individual reporting. These reports must be submitted via the MORE portal and reviewed within the PMSR and PSUR, following the content requirements now established.

Manufacturers must submit a trend report to the MHRA when they observe a significant increase in the frequency or severity of incidents compared to expected thresholds. This ensures timely risk assessment and corrective actions to maintain device safety. 

Trend reporting helps detect emerging safety concerns before they escalate and impact benefit-risk ratio.

3.    Field safety corrective actions (FSCA): Ensuring Patient Safety

FSCA is a critical tool for manufacturers to mitigate risks associated with faulty devices. Manufacturers must:
•    Conduct a risk assessment for any proposed Field Safety Corrective Action (FSCA) 
•    Submit an initial report to the MHRA detailing the planned actions. 
•    If urgent action is required, issue a Field Safety Notice (FSN) immediately, with manufacturers ensuring it reaches all affected users.
•    Submit a final report to the MHRA once the FSCA is completed, outlining the outcome and providing evidence of the action’s effectiveness.

What Qualifies as an FSCA?

An action is classified as an FSCA if it meets all three criteria:
1.    Field – The affected devices have already been distributed or supplied to users.
2.    Safety – There is a risk of death or serious deterioration in health.
3.    Corrective Action – Actions are taken to reduce or eliminate the risk.

4.    Field safety corrective actions (FSCA) outside GB: When to notify the MHRA

If a manufacturer implements an FSCA outside GB for a device of the same model as one available in GB, they must notify the MHRA by submitting a report.
Exception: This reporting requirement does not apply if the same FSCA is being carried out within GB as well.